This invention generally relates to a mammary prosthesis, also known as a breast implant, with foamed or expanded and furthermore preferably thermoexpanded polymer microspheres. The inventive implant constitutes an alternative to the existing implants with silicone gel and/or saline solution filling, offering advantages over the existing implants, facilitating removal, mitigating the consequences from ruptures within the mammary pocket (Surgical space formed to place the implant), such as the formation of siliconomas and seromas, a more natural feel to the touch once it is placed, reduced weight and easier removal from the mammary pocket.
Mammary prosthesis or breast implants are indicated in the aesthetic augmentation of breasts and the secondary reconstruction of surgical ablation as an oncological treatment or due to trauma. This surgical indication is found within the reconstructive surgery and cosmetic plastic field. With regard to mammary prosthesis (Breast Implants), developments started over 30 years ago. Research has been done on elastic and resistant wrappings with long term reliability, as well as the use of highly cohesive silicone gel filling, saline solution filling, and soy oil (trilucent).
Due to the technological developments and the broad existing market for this product it is determined to venture in the development of implants for different parts of the body, such as breast, buttocks or testicular implants, among others where the filling is not liquid or a gel, or its combination, and that reduces the complications of the current ones such as deflation and gel migration that can result in seromas, siliconomas, and adenopathies, consequences due to ruptures within the mammary cavity, and a ruptured implant replacement.
As it is mentioned, the existing art in terms of implants presents several disadvantages that are intended to be overcome with the proposed invention, becoming an alternative to what already exists as explained below. In comparison to the generality of the implants, the proposed invention presents advantages in case of rupture avoiding the complications with the existing implants. In the case of saline solution filled implants, it has been observed that once placed, these lose volume over time; and have a less natural feel to the touch, something that is intended to be overcome with the present invention. With regards to silicone gel filled implants, the density of the gel can result in a much heavier implant, and in the event of a rupture, the leak or migration of the gel into the interior of the mammary pocket (Capsule formed by scaring tissue), or even extracapsular leakage can make its removal difficult and produce seromas or siliconomas, which is mitigated by the present invention, by allowing an easier removal of the filling if it ruptures, due to its characteristic shape and defined consistency, not of a fluid. Additionally, because of the easier removal due to the proposed implant characteristics, the resistance improves on account of the expanded polymer microsphere filling; it reduces the weight of the implant and presumably offers a more natural feel to the touch once it is placed.
A breast augmentation using mammary implants must be done in a surgical environment (operating room), by surgeons specialized in plastic surgery. Among the surgical techniques, to do this type of procedure, the surgeon must use entry routes depending on the area of the scar. The most used entry route is the areola (around the nipple). A second modality is the axillary route (in the armpit) and a third commonly used route is the sub-mammary, which is done in the inferior fold of the breasts.
As such, the implant must be placed in one of the two available places in the human body, the prepectoral located between the mammary gland and the retro-pectoral, behind the mayor pectoral muscle. It is the surgeon's responsibility to assess the size and shape of the implant, where the incision will be made in the breasts, the approach, and the criteria for positioning the implant as a function of the patient's anatomy and the expected aesthetic results.
Some combined systems have been developed, which include gel with silicone microspheres. This development is found in the U.S. Pat. No. 4,380,569 issued to Shaw on Apr. 19, 1983, where a mammary prosthesis is described with a reduced weight and made of a mixture of a gel and silicone microspheres dispersed within the fluid. In this proposal the weight is reduced, but the problem of liquid pressure, friction, and the use of gel persists, with the disadvantages already mentioned.